A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Terminated
Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo to MK-3577
Drug: Metformin
Drug: Placebo to Metformin
Drug: MK-3577

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868790
3577-009
CTRI/2009/091/000614 (Registry Identifier)
2009_564 (Other Identifier)

Details and patient eligibility

About

This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM) administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG) levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well tolerated compared to placebo.

Full description

This was a 4-period/5-treatment crossover study. Each period was 4 weeks. The 5 treatments consisted of MK-3577 10 mg once daily (QD) in the AM, MK-3577 6 mg QD in the evening (PM), MK-3577 25 mg twice daily (BID), metformin 1000 mg BID, and placebo to MK-3577/placebo to metformin. Participants were to be randomized to one of 14 treatment sequence arms. A subset of participants in each group was to domicile (stay overnight) at selected clinical sites at Baseline, Week 4 (end of Period 1), and Week 8 (end of Period 2) to undergo 24-hr blood sample.

Enrollment

118 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participant has type 2 diabetes
  • Participant is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a Peroxisome Proliferator-Activated Receptor gamma [PPARg] agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose
  • Female participant is unable to have children

Exclusion criteria

  • Participant has a history of type 1 diabetes or ketoacidosis
  • Participant has been treated with a PPARg agonist in the last 12 weeks
  • Participant has been treated with insulin in the last 12 weeks
  • Participant has had prescription lipid-modifying drug therapy in the last 12 weeks
  • Participant has a history of coronary artery disease
  • Participant has had a stroke or transient ischemic attack
  • Participant has congestive heart failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

118 participants in 14 patient groups

PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)
Experimental group
Description:
Participants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
Treatment:
Drug: MK-3577
Drug: Placebo to Metformin
Drug: Placebo to MK-3577
MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
Treatment:
Drug: MK-3577
Drug: Placebo to Metformin
Drug: Placebo to MK-3577
MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)
Experimental group
Description:
Participants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)
Experimental group
Description:
Participants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
Treatment:
Drug: MK-3577
Drug: Placebo to Metformin
Drug: Placebo to MK-3577
MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants were also to receive placebo to metformin during Period 1 and Period 2.
Treatment:
Drug: MK-3577
Drug: Placebo to Metformin
Drug: Placebo to MK-3577
MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)
Experimental group
Description:
Participants were to receive oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
Treatment:
Drug: MK-3577
Drug: Placebo to MK-3577
PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)
Experimental group
Description:
Domiciled participants were to receive oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
Treatment:
Drug: MK-3577
Drug: Placebo to Metformin
Drug: Metformin
Drug: Placebo to MK-3577
METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)
Experimental group
Description:
Domiciled participants were to receive oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
Treatment:
Drug: MK-3577
Drug: Placebo to Metformin
Drug: Metformin
Drug: Placebo to MK-3577

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems